Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk
Baxter Healthcare is recalling 110,134 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential leak in a medical device used for intravascular administration, which presents a risk of harm to patients, but the source text does not report specific injuries or illnesses.
Plain-English summary
Baxter Healthcare Corporation is recalling 110,134 units of Exactamix Empty EVA Bags (500 mL). These plastic containers are used to hold large-volume sterile solutions that are administered to patients through intravascular administration sets.
The recall was initiated because the bags have the potential to leak once they have been used for compounding. The affected product was distributed worldwide, including nationwide in the United States and in Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, and Uruguay.
The specific product code is H938738. The recall includes lot numbers 60055343, 60080326, 60081686, 60084628, 60084630, 60091155, 60098887, and 60103959. An update on February 19, 2019, expanded the recall to include lot numbers 60066390, 60072129, 60084627, 60089799, 60104861, 60108274, 60109594, and 60126011. Healthcare facilities should stop using these bags and contact Baxter Healthcare for instructions on returning the product.
The recalled product
- Product
- EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Bags
- Hazard
- Affected units
- 110,134
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Product Code H938738 Lot #'s: 60055343
- 60080326
- 60081686
- 60084628
- 60084630
- 60091155
- 60098887
- and 60103959. **Update expansion on 02/19/2019 with lot numbers: 60066390
- 60072129
- 60084627
- 60089799
- 60104861
- 60108274
- 60109594
- 60126011.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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